Locking needle for inflatable penile prosthesis

ABSTRACT

Disclosed is a locking needle to be used with a Furlow insertion tool during penile prosthesis. The invention also provides methods of using the locking needle for the implantation of a penile prosthesis cylinder.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims benefit under 35 U.S.C. § 119(e) to U.S. Ser.No. 61/993,120, filed May 14, 2014, the contents of both of which areincorporated herein by reference in their entirety.

FIELD OF THE INVENTION

The invention relates generally to penile prosthesis implantation usinga locking needle.

BACKGROUND OF THE INVENTION

A penile prosthetic typically includes non-inflatable semirigidcylinders that are implanted in the corpora cavernosa of the penis. Aninflatable penile prosthetic generally includes a liquid reservoirimplanted in the abdomen that communicates with the cylinders, and apump, often located in the scrotum, that is employed to move liquid fromthe liquid reservoir into the cylinders.

In a typical inflatable application, the user squeezes a bulb of thepump multiple times to incrementally draw liquid out of the liquidreservoir, into the bulb, and eventually into the cylinders. Therepeated squeezing of the bulb moves the liquid from the reservoir intothe cylinders, which incrementally deflates the reservoir andincrementally inflates the cylinders to eventually provide the user withan erect penis. The user may return the penis to its flaccid state byselectively transferring the liquid from the cylinders back into thereservoir.

Penile prosthesis is an invasive treatment that requires a delicate andoften painful implant to surgically install. To reach the corpuscavernosa and implant the cylinders, the surgeon will first make anincision at the base of the penis, such as where it meets the scrotum.The patient is prepared for the cylinder after the surgeon has dilatedeach corpus cavernosum to create space for the cylinders.

Once the patient has been prepared, the surgeon will insert a medicaldevice known as a Furlow insertion tool (U.S. Pat. No. 4,244,370)containing a Keith needle into the dilated corpus cavernosum. The Furlowinsertion tool is a long slender device having a hollow barrel with aobturator at the rearward end. A Keith needle is used in many areas ofmedicine having a design much like that of a heavy straight sewingneedle used to pierce tissue. The Keith needle fits within the bore ofthe Furlow insertion tool's barrel and is ejected from the forward endwith the obturator.

In order to install the implant, the Keith needle is tethered to theimplantable cylinder by a suture. The current prosthesis procedure, forexample, as described in U.S. Pat. Pub. No. 20040167574, requires thethreading of two ends of the suture through the eye of the Keith needleand manipulation of the resulting free ends of the suture before andduring installation of the implant. This can be cumbersome and decreasethe overall efficiency of the procedure.

Thus, there is a need for a solution that effectively alleviates thecurrent problems associated with the implantation of inflatable penileprosthesis.

BRIEF SUMMARY OF THE INVENTION

Solutions to problems associated with penile prosthesis implantationhave been discovered. The present disclosure provides a locking needlefor use in a Furlow insertion tool during implantation of penileprosthesis.

In a single embodiment the disclosure provides a locking needle for theimplementation of a penile prosthesis cylinder, the locking needleadapted for insertion into a Furlow insertion tool, wherein the needlecontains a locking groove, and wherein a continuous suture loop canengage the graduated groove of the needle and become locked. In someaspects the graduated groove of the locking needle can secure thecontinuous suture loop by the use of a detachable sleeve that covers andsecures the suture in the graduated groove, by a forward or rearwardopening gate (that fits over the groove), and/or by a ridge or notchwithin the graduated groove. In one embodiment, the sleeve should beslidable or could be screwed around the shaft of the needle so that theinteraction between the sleeve and shaft of the needle is tight but canstill be slid along the shaft surface. In one aspect, the sleeve is oftubular form and can be threaded so that the sleeve fits along a portionor along the entire shaft of the needle. Where the sleeve is threaded,the needle shaft would also be threaded opposite to that of the threadof the sleeve so as to secure the sleeve to the needle shaft. Thecontinuous suture which is also tethered to the cylinder of the penileprosthesis to be implanted eliminates the need to thread two suture endsthrough a Keith needle and fumbling with the suture ends during surgery.

In another embodiment the disclosure provides a surgical tool for theimplementation of a penile prosthesis cylinder that includes a lockingneedle and a Furlow insertion tool. The surgical tool is used for theimplementation of a penile prosthesis cylinder. The locking needle isprovided within the barrel of the Furlow insertion tool, wherein thelocking needle contains a graduated groove, and wherein a continuoussuture loop can engage the graduated groove of the locking needle andbecome affixed thereto, e.g., locked. In some aspects the graduatedgroove of the locking needle can secure the continuous suture loop bythe use of a detachable sleeve, a forward or rearward opening gate,and/or by a ridge or notch within the graduated groove. The continuoussuture which is also tethered to the penile prosthesis cylinder to beimplanted eliminates the need to thread two suture ends through a Keithneedle and fumbling with the suture ends during surgery.

The locking needle of the current embodiments can be constructed of analloy including titanium, chromium, nickel, cobalt, molybdenum, orcombinations thereof, and also contain a suitable stabilizer includingaluminum, gallium, germanium, carbon, oxygen, nitrogen, molybdenum,vanadium, tantalum, niobium, manganese, iron, chromium, cobalt, nickel,copper, silicon, or combinations thereof.

Disclosed are methods to implant a cylinder during penile prosthesisusing a locking needle, the method can include (a) threading a suturethrough the distal end of the cylinder and securing the two ends of thesuture together to form a continuous suture loop; (b) securing thecontinuous suture loop to the locking needle; (c) inserting the lockingneedle into a Furlow insertion tool; (d) inserting the Furlow insertiontool containing locking needle into the corpus cavernosum; (e)positioning the locking needle through the glans of the penis andwithdrawing the Furlow insertion tool from the corpus cavernosum; (f)manipulating the locking needle and continuous suture loop and pullingthe cylinder into the corpus cavernosum; and (g) cutting the continuoussuture loop and removing the cut suture from the glands of the penis.Step (b) and step (c) can be reversed where the Furlow insertion tool ispreloaded with the locking needle.

Also disclosed are methods to employ a surgical tool during theimplantation of a penile prosthesis cylinder, the method can include (a)threading a suture through the distal end of the cylinder and securingthe two ends of the suture together to form a continuous suture loop;(b) securing the continuous suture loop to the locking needle; (c)inserting the locking needle into a Furlow insertion tool; (d) insertingthe surgical tool into the corpus cavernosum; (e) positioning thelocking needle through the glans of the penis and withdrawing the Furlowinsertion tool from the corpus cavernosum; (f) manipulating the lockingneedle and continuous suture loop and pulling the cylinder into thecorpus cavernosum; and (g) cutting the continuous suture loop andremoving the cut suture from the glans of the penis. Step (c) can beomitted where the surgical tool is preloaded with the locking needle. Inone aspect, the locking needle of the preloaded surgical tool includes aforward opening gate.

Disclosed are kits to implant a penile prosthesis cylinder using thelocking needle, the kit including (a) a locking needle; (b) instructionsfor using the kit and/or locking needle; and optional sutures.

Also disclosed are kits to implant a penile prosthesis cylinder usingthe surgical tool, the kit including (a) a Furlow insertion tool; (b) alocking needle; (c) instructions for using the kit and/or surgical tool;and optional sutures.

While multiple embodiments are disclosed, still other embodiments of thepresent invention will become apparent to those skilled in the art fromthe following detailed description. As will be apparent, the inventionis capable of modifications in various obvious aspects, all withoutdeparting from the spirit and scope of the present invention.Accordingly, the detailed descriptions are to be regarded asillustrative in nature and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1A. An illustration of a locking needle that includes a graduatedgroove is provided. FIG. 1B shows the locking needle of FIG. 1A with aridge and FIG. 1C shows the locking needle of FIG. 1A with a notch.

FIG. 2. An illustration of a locking needle that includes a graduatedgroove and rearward closing gate is provided.

FIG. 3. An illustration of a locking needle that includes a graduatedgroove and a forward closing gate is provided.

FIG. 4. An illustration of a locking needle that includes a graduatedgroove and a sleeve is provided.

FIG. 5. An illustration of a continuous suture that is looped through animplantable medical device and a locking needle as described herein isprovided. The locking needle is inserted into the barrel of a Furlowinsertion tool prior to the time when the Furlow insertion tool isinserted into a corpus cavernosum.

DETAILED DESCRIPTION

In the specification and in the claims, the terms “including” and“comprising” are open-ended terms and should be interpreted to mean“including, but not limited to . . . .” These terms encompass the morerestrictive terms “consisting essentially of” and “consisting of.”

It must be noted that as used herein and in the appended claims, thesingular forms “a”, “an”, and “the” include plural reference unless thecontext clearly dictates otherwise. As well, the terms “a” (or “an”),“one or more” and “at least one” can be used interchangeably herein. Itis also to be noted that the terms “comprising”, “including”,“characterized by” and “having” can be used interchangeably.

Unless defined otherwise, all technical and scientific terms used hereinhave the same meanings as commonly understood by one of ordinary skillin the art to which this invention belongs. All publications and patentsspecifically mentioned herein are incorporated by reference in theirentirety for all purposes including describing and disclosing thechemicals, instruments, statistical analyses and methodologies which arereported in the publications which might be used in connection with theinvention. All references cited in this specification are to be taken asindicative of the level of skill in the art. Nothing herein is to beconstrued as an admission that the invention is not entitled to antedatesuch disclosure by virtue of prior invention.

A discovery has been made that solves problems associated with penileprosthesis implantation. The present disclosure provides a lockingneedle for use in a Furlow insertion tool during implantation of apenile prosthesis. It is envisioned without limitation, that the lockingneedle, surgical tool, and methods disclosed herein can be used for theimplantation of Coloplast's male urology products including, forexample, Titan®, Genesis®, Alpha I®, Excel™, and Mark II® penileimplants for the treatment of erectile dysfunction. It is alsoenvisioned that the locking needle, surgical tool, and methods disclosedherein can be used for the implantation of other brands of penileprosthetics including Promedon-Tube® (Cordoba, Argentina); Silimed®prosthesis (Rio de Janerio, Brazil); Jonas® prosthesis by Bard Co.(Murray Hill, N.J., USA); Virilis I™ and Virilis II™ prostheses by GiantMedical (Cremona, Italy); Apollo™ prosthesis by Giant MedicalCorporation (Cremona, Italy); AMS 600™, AMS 650™, Dura II™, Ambicor®,and AMS 700™ series 700 CX, Ultrex, and CXR by American Medical Systems(Minnetonka, Minn., USA). Both inflatable and non-inflatable semirigidpenile implants can be used.

In a single embodiment the disclosure provides a locking needle for theimplementation of a penile prosthesis. In another embodiment, a surgicaltool for the implementation of a penile prosthesis, the surgical toolcomprising a Furlow insertion tool and a locking needle adapted forinsertion into the Furlow insertion tool, wherein the needle contains agraduated groove, and wherein a continuous suture loop can engage andlock into the graduated groove of the needle. The disclosure therebyeliminates the need to thread two suture ends through a Keith needle andfumbling with the suture ends during surgery.

The Furlow insertion tool of U.S. Pat. No. 4,244,370 is incorporatedhere within by reference in its entirety. The Furlow insertion toolincludes a hollow barrel having an obturator slidably mounted thereinand having a rounded forward end. A locating device is attached to thebarrel to stabilize the obturator in the plurality of predeterminedpositions as it is moved along the bore of the barrel. A needle havingsuture material attached may be placed within the bore of the barrel. Aslot is located along the length of the barrel to allow the suturematerial to exit from the side of the barrel. In practice, the tool maybe inserted into a bodily structure such as one of the corpora cavernosaof a penis. The outer surface of the barrel is equipped with a pluralityof markings that allow the user to gauge the depth that the barrel hasbeen inserted into a bodily structure. After the tool is inserted, theobturator is slid along the barrel bore to force the needle out of therounded forward end of the barrel. The needle is manually pulled out ofthe bodily structure. After the tool is withdrawn, suture materialremains threaded through the bodily structure.

The Furlow insertion tool of the current embodiments is adapted for usewith the a locking needle. The locking needle fits within the barrelbore of the Furlow insertion tool and is ejected from the forward end bymanipulation of the obturator. The bore of the Furlow insertion tool hassuch a diameter that the locking needle is adapted to be disposed withinthe bore and ejected without undesired resistance.

Referring to FIG. 1, an illustration of the locking needle including agraduated groove used with a Furlow insertion tool is described. In FIG.1, locking needle 10 includes shaft 40 with tip 20 and end 30 havinggraduated groove 50 along shaft 40. Graduated groove 50 can be locatedalong shaft 40 near tip 20, near end 30, or anywhere in between. Thedepth and size of graduated groove 50 is appropriate to engage a strandor strands of one or more sutures. In some non-limiting embodiments,graduated grove 50 is graduated and includes an additional ridge 50 a(FIG. 1B) or notch 50 b (FIG. 1C) within the groove 50 to help secure orlock an incoming suture or sutures. In another aspect, graduated groove50 can have a T-shape, L-shape, V-shape, or U-shape.

Referring to FIG. 2, an illustration of the locking needle including agraduated groove and a rearward opening gate used with a Furlowinsertion tool is described. In FIG. 2, locking needle 60 containsrearward opening gate 55 attached to shaft 80 by hinge 56. Rearwardopening gate 55 may be fitted to snap or secure onto shaft 80 or can bespring loaded to enclose and lock a suture within graduated groove 95 ofneedle 60. In another aspect, rearward opening gate 55 may also bepositioned inside graduated groove 50 and have a latching mechanism likethat of a carabineer. Graduated groove 50 and corresponding rearwardopening gate 55 of locking needle 60 can be located along shaft 80 neartip 70, near end 90, or anywhere in between.

Referring to FIG. 3, an illustration of the locking needle including agraduated groove and a forward opening gate used with a Furlow insertiontool is described. In FIG. 2, locking needle 100 includes shaft 120 withtip 110 and end 130 with forward opening gate 115 attached to shaft 120by hinge 116. Forward opening gate 115 may be fitted to snap or secureonto shaft 120 or can be spring loaded to enclose and lock a suturewithin graduated groove 135 of needle 100. Forward opening gate 115 canhave a curved or hooked shaped tip 117. Curved or hooked shaped tip 117can be forked or shaped any way appropriately to fit securely to shaft120 It is envisioned that having forward opening gate 115 will permitlocking needle 100 to be preloaded into a Furlow insertion tool andcurved or hooked shaped tip 117 will allow easy lassoing of a suture orsutures by the surgeon. Preloaded locking needle 100 will also speed upthe prosthesis procedure and eliminate unnecessary handing of lockingneedle 100. Graduated groove 135 and corresponding forward opening gate115 of locking needle 100 can be located anywhere along shaft 120, butpreferably near tip 110.

Referring to FIG. 4, an illustration of the locking needle including agraduated groove and a sleeve used with a Furlow insertion tool isdescribed. In FIG. 4, locking needle 200 includes shaft 230 with tip 210and end 220. Sleeve 250 can be slid along shaft 230 to lock a suture orsutures with graduated groove 240. Sleeve can be detachable andconstitute any suitable medical material and function as readilyapparent to those skilled in the art, in view of the present disclosure.

The piercing point of the tips 20, 70, 110, 210 of locking needles 10,60, 100, 200 can be tapered, tapered triangular (tricut), trocar,tapercut, or chiseled. The blunt ends 30, 90, 130, 220 of lockingneedles 10, 60, 100, 200 can be flat or rounded.

Locking needles 10, 60, 100, 200 comprises a surgical stainless steelwhich includes grades of stainless steel that are used in biomedicalapplications. The most common surgical steels are austenitic 316stainless and martensitic 440 and 420 stainless steels. However thestainless steel can be any grade of corrosion resistant steel. Commonly316 stainless steel, also referred to as “Marine Grade Stainless Steel”,is a chromium, nickel, molybdenum alloy of steel that exhibitsrelatively good strength and corrosion resistance. 440 and 420 stainlesssteels, known also by the name “Cutlery Stainless Steel”, are highcarbon steels alloyed with chromium that have very good corrosionresistance compared to other cutlery steels, but their corrosionresistance is inferior to 316 stainless. Biomedical cutting instrumentsare often made from 440 or 420 stainless due to its high hardnesscoupled with acceptable corrosion resistance.

Locking needles 10, 60, 100, 200 may comprise at least chromium, nickel,or molybdenum, and combinations thereof. Other metals and alloyscommonly used as biomaterials are gold (Au), cobalt-chrome alloys(CoCr), titanium and titanium alloys (TiNi, Ti-6Al-4V, Ti—Al—V,Ti—Al—Mo, Ti—Al—Cr, Ti—Al—Cr—Co, Ti—Al—Nb, Ti—Zr—Al) and silver-mercuryalloys (AgHg). Titanium alloys may contain alpha stabilizers (aluminium,gallium, germanium, carbon, oxygen and nitrogen) or beta stabilizers(molybdenum, vanadium, tantalum, niobium, manganese, iron, chromium,cobalt, nickel, copper and silicon). Of the number of titanium alloysknown, Ti-6Al-4V is most commonly employed, however Ti-6Al-6Nb showseven greater strength and resistance to corrosion.

Referring to FIG. 5, an illustration of the surgical tool comprising alocking needle and a Furlow insertion tool is described. In FIG. 2,continuous suture loop 370 is looped through distal end 400 ofimplantable cylinder 405 and graduated groove 350 of locking needle 310.FIG. 2 also depicts locking needle 310 being inserted into forward end335 of Furlow insertion tool 360 prior to insertion of Furlow insertiontool 360 into the corpus cavernosum. Only part of Furlow insertion tool360 and implantable cylinder 405 are shown in FIG. 5.

Continuous suture loop 370 comprises a continuous loop wherein the twofree ends of a suture are fastened together to form a continuous loop toinclude implantable cylinder 405 at distal end 400. The suture is thenstretched to form a longitudinal strand and the other end is lassoed tograduated groove 350 of locking needle 310. There is no particularlimitation on the locking mechanism of locking needle 310 as part of thesurgical tool. Locking needle 310 can secure continuous suture loop 370by the use of a detachable sleeve, a forward or rearward opening gate,and/or by a ridge or notch within graduated groove 350. A surgeon canhold locking needle 310 in one hand including tethered continuous sutureloop 370 and implantable cylinder 405. The surgeon can use the free handto grasp Furlow 60 and slide locking needle 310 into the barrel (notshown) at forward end 335 of Furlow insertion tool 360 having continuoussuture loop 370 pass through barrel slot 380. Locking needle 310 can bepulled into place using continuous suture loop 370 and can fit snugglydue to friction between continuous suture loop 370 and locking needle310 within the barrel of Furlow insertion tool 360.

After locking needle 310 has been inserted into the barrel of Furlowinsertion tool 360, it is ready for insertion in a body cavity. Thesurgical tool contemplated herein can be used for the implantation of aninflatable prosthesis into the corpora cavernosa of a penis. Herein aFurlow insertion tool 360 may be used for the implementation of a penileprosthesis, comprising a locking needle 310 adapted for insertion intothe Furlow insertion tool 360, wherein the needle contains a graduatedgroove 350, and wherein a continuous suture loop 370 can engage thegraduated groove 360 of the locking needle 310, thereby eliminating theneed to thread two suture ends through a Keith needle and fumbling withthe suture ends during surgery.

After Furlow insertion tool 360 is fully inserted into the corpuscavernosum and locking needle 310 is plunged out of the bore of thebarrel of Furlow insertion tool 360 through the glans of the penis,locking needle 310 is then manipulated by the surgeon from outside thebody and pulled from the penis. Furlow insertion tool 360 can then bewithdrawn from the corpus cavernosum and implantable cylinder 405 pulledinto place by continuous suture loop 370. Continuous suture loop 370 canthen be cut and one strand pulled from the glans removing entire cutcontinuous suture loop 370. The above described procedure may berepeated to insert a second implant in the second corpora cavernosum.

In another embodiment the surgical tool can be used with a preloadedlocking needle having a forward opening gate. The forward opening gatepermits the lassoing of the suture without unnecessary handling of thelocking needle for insertion into the surgical tool. Once the suture islassoed around the locking needle the forward opening gate is thenclosed securing the suture to the locking needle. It is plausible thatthe locking needle with the forward opening gate may not require agroove as the suture may be sufficiently secured to the locking needlewithin the closed forward opening gate. In this aspect, the lockingneedle will have a lesser risk of contamination and the time of theprosthesis procedure will be shortened.

Applicant anticipates that the locking needle and surgical tooldescribed herein may be used for such other medical purposes assurgically relocating body organs, particularly for the purpose ofrepositioning testicles.

Kits are also contemplated as being used in certain aspects of theinvention. For instance, the locking needle or surgical tool of thepresent invention can be included in a kit. A kit can include acontainer. Containers can include a case, sachet, pouch, package,compartment or other containers into which the surgical tool isretained. The kit can include indicia on its surface. The indicia, forexample, can be a word, a phrase, an abbreviation, a picture, or asymbol. A kit can also include instructions for using the kit, lockingneedle and/or surgical tool.

Further, the locking needle or surgical tool of the present inventionmay also be sterile, and the kits containing such tools can be used topreserve the sterility. The surgical tools may be sterilized via anaseptic manufacturing process or sterilized after packaging by methodsknown in the art.

The following paragraphs enumerated consecutively from 1 through 33provide for various aspects of the present invention. In one embodiment,in a first paragraph (1), the present invention provides:

A needle, wherein the needle comprises a locking groove within the shaftof the needle.

2. The needle according to paragraph 1, wherein the locking groove ofthe shaft of the needle is graduated.

3. The needle according to paragraph 2, wherein a continuous suture loopis locked within the graduated locking groove of the shaft of theneedle.

4. The needle according to paragraph 3, wherein the continuous sutureloop further comprises a penile prosthesis cylinder.

5. The needle according to any of paragraphs 1 through 3, wherein thelocking groove further comprises a ridge or notch.

6. The needle according to any of paragraphs 1 through 3, wherein thelocking groove further comprises a rearward opening gate.

7. The needle according to any of paragraphs 1 through 3, wherein thelocking groove further comprises a forward opening gate.

8. The needle according to paragraph 7, wherein the forward opening gatefurther comprises a curved or hooked tip.

9. The needle according to paragraph 1, wherein the needle furthercomprises a sleeve that slidably fits over the shaft of the needle.

10. The needle according to any of paragraphs 1 through 9, wherein theneedle comprises an alloy including titanium, chromium, nickel, cobalt,molybdenum, or combinations thereof.

11. The surgical tool according to paragraph 10, wherein the alloyfurther comprises a stabilizer including aluminum, gallium, germanium,carbon, oxygen, nitrogen, molybdenum, vanadium, tantalum, niobium,manganese, iron, chromium, cobalt, nickel, copper, silicon, orcombinations thereof.

12. The needle according to paragraph 4, wherein the needle is usedduring the implantation of a penile prosthesis cylinder.

13. A surgical tool for the implementation of a penile prosthesis,comprising a Furlow insertion tool and a needle adapted for insertioninto the Furlow insertion tool, wherein the needle contains a lockinggroove along the shaft of the needle.

14. The surgical tool according to paragraph 13, wherein the lockinggroove of the needle is graduated from a wide opening to a narrowopening that can be V like in structure.

15. The surgical tool according to paragraph 14, wherein a continuoussuture loop is locked within the graduated locking groove of the needle.

16. The surgical tool according to paragraph 15, wherein the continuoussuture loop further comprises a penile prosthesis cylinder.

17. The surgical tool according to paragraph 13, wherein the lockinggroove further comprises a ridge or notch.

18. The surgical tool according to paragraph 13, wherein the lockinggroove further comprises a rearward opening gate.

19. The surgical tool according to paragraph 13, wherein the lockinggroove further comprises a forward opening gate.

20. The surgical tool according to paragraph 19, wherein the forwardopening gate further comprises a curved or hooked tip.

21. The surgical tool according to paragraph 13, wherein the needlefurther comprises a sleeve that is slidably attached to the shaft of theneedle that can cover the graduated groove in the shaft of the needle tohelp secure a suture.

22. The surgical tool according to any of paragraphs 13 through 21,wherein the needle comprises an alloy including titanium, chromium,nickel, cobalt, molybdenum, or combinations thereof.

23. The surgical tool according to paragraph 22, wherein the alloyfurther comprises a stabilizer including aluminum, gallium, germanium,carbon, oxygen, nitrogen, molybdenum, vanadium, tantalum, niobium,manganese, iron, chromium, cobalt, nickel, copper, silicon, orcombinations thereof.

24. The surgical tool according to paragraph 16, wherein the surgicaltool is used during the implantation of a penile prosthesis cylinder.

25. A method to implant a cylinder during penile prosthesisimplementation using a locking needle, the method comprising:

(a) threading a suture through the distal end of the cylinder andsecuring the two ends of the suture together to form a continuous sutureloop;

(b) securing the continuous suture loop to the locking needle, whereinthe locking needle has a groove along a portion of the shaft of theneedle;

(c) inserting the locking needle into a Furlow insertion tool;

(d) inserting the Furlow insertion tool containing the locking needleinto the corpus cavernosum;

(e) positioning the locking needle through the glans of the penis andwithdrawing the Furlow insertion tool from the corpus cavernosum;

(f) manipulating the locking needle and continuous suture loop andpulling the cylinder into the corpus cavernosum; and

(g) cutting the continuous suture loop and removing the cut suture fromthe glans of the penis.

26. The method according to paragraph 25, wherein step (b) and step (c)are reversed and the Furlow insertion tool is preloaded with the lockingneedle.

27. A method to implant a cylinder during penile prosthesis using thesurgical tool of paragraph 13, the method comprising:

(a) threading a suture through the distal end of the cylinder andsecuring the two ends of the suture together to form a continuous sutureloop;

(b) securing the continuous suture loop to the locking needle;

(c) inserting the locking needle into a Furlow insertion tool;

(d) inserting the surgical tool into the corpus cavernosum;

(e) positioning the locking needle through the glans of the penis andwithdrawing the Furlow insertion tool from the corpus cavernosum;

(f) manipulating the locking needle and continuous suture loop andpulling the cylinder into the corpus cavernosum; and

(g) cutting the continuous suture loop and removing the cut suture fromthe glans of the penis.

28. The method according to paragraph 27 omitting step (c), wherein thesurgical tool is preloaded with the locking needle.

29. The method according to paragraph 28, wherein the locking needle ofthe preloaded surgical tool comprises a forward opening gate.

30. A kit to implant a penile prosthesis cylinder, the kit comprising:

(a) the locking needle of any of paragraphs 1 through 12; and

(b) instructions for using the locking needle.

31. The kit according to paragraph 30, wherein the kit further comprisessutures.

32. A kit to implant an penile prosthesis cylinder using the surgicaltool of any of paragraphs 13 through 24, the kit comprising:

(a) a Furlow insertion tool;

(b) the locking needle; and

(c) instructions for using the kit and/or surgical tool.

33. The kit according to paragraph 32, wherein the kit further comprisessutures.

The above description is given by way of example, and not limitation.Given the above disclosure, one skilled in the art could devisevariations that are within the scope and spirit of the inventiondisclosed herein, including various ways of surgically implanting theimplants described herein. Further, the various features of theembodiments disclosed herein can be used alone, or in varyingcombinations with each other and are not intended to be limited to thespecific combination described herein. Thus, the scope of the claims isnot to be limited by the illustrated embodiments.

What is claimed is:
 1. A system for implanting a penile prosthesis, thesystem comprising a needle, wherein the needle comprises a lockinggroove within the shaft of the needle and the locking groove furthercomprises a ridge or notch.
 2. The system according to claim 1, whereinthe locking groove of the shaft of the needle is graduated.
 3. Thesystem according to claim 2, further comprising a continuous suture loopthat is locked within the graduated locking groove of the shaft of theneedle.
 4. The system according to claim 3, further comprising a penileprosthesis cylinder, and further wherein the continuous suture loop iscoupled to the penile prosthesis cylinder.
 5. A needle for implanting apenile prosthesis, the system comprising a needle, wherein the needlecomprises a locking groove within the shaft of the needle and thelocking groove further comprises a ridge or notch, wherein the lockinggroove further comprises a rearward opening gate.
 6. The systemaccording to claim 1, wherein the locking groove further comprises aforward opening gate.
 7. A system for implanting a penile prosthesis,the system comprising a needle, wherein the needle comprises a lockinggroove within the shaft of the needle, wherein the locking groovefurther comprises a forward opening gate, and wherein the forwardopening gate further comprises a curved or hooked tip.
 8. The systemaccording to claim 1, wherein the needle further comprises a sleeve thatslidably fits over the shaft of the needle.
 9. The system according toclaim 1, wherein the needle comprises an alloy including titanium,chromium, nickel, cobalt, molybdenum, or combinations thereof.
 10. Thesystem according to claim 9, wherein the alloy further comprises astabilizer including aluminum, gallium, germanium, carbon, oxygen,nitrogen, molybdenum, vanadium, tantalum, niobium, manganese, iron,chromium, cobalt, nickel, copper, silicon, or combinations thereof. 11.A system for the implementation of penile prosthesis, comprising aFurlow insertion tool and a needle adapted for insertion into the Furlowinsertion tool, wherein the needle contains a locking groove along theshaft of the needle, wherein the locking groove further comprises aridge or notch.
 12. The system according to claim 11, wherein thelocking groove of the needle is graduated.
 13. The system according toclaim 12, further comprising a continuous suture loop is locked withinthe graduated locking groove of the needle.
 14. The system according toclaim 13, further comprising a penile prosthesis cylinder, wherein thecontinuous suture loop is coupled to the penile prosthesis cylinder. 15.A surgical tool for the implementation of penile prosthesis, comprisinga Furlow insertion tool and a needle adapted for insertion into theFurlow insertion tool, wherein the needle contains a locking groovealong the shaft of the needle, wherein the locking groove furthercomprises a rearward opening gate.
 16. A surgical tool for theimplementation of penile prosthesis, comprising a Furlow insertion tooland a needle adapted for insertion into the Furlow insertion tool,wherein the needle contains a locking groove along the shaft of theneedle, wherein the locking groove further comprises a forward openinggate and the forward opening gate further comprises a curved or hookedtip.
 17. The system according to claim 11, wherein the needle furthercomprises a sleeve that is slidably attached to the shaft of the needle.18. The system according to claim 11, wherein the needle comprises analloy including titanium, chromium, nickel, cobalt, molybdenum, orcombinations thereof.
 19. The system according to claim 18, wherein thealloy further comprises a stabilizer including aluminum, gallium,germanium, carbon, oxygen, nitrogen, molybdenum, vanadium, tantalum,niobium, manganese, iron, chromium, cobalt, nickel, copper, silicon, orcombinations thereof.
 20. The system according to claim 14, wherein thesurgical tool is used during the implantation of a penile prosthesiscylinder.